BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 21755959 · Received April 2, 2025

    Report

    Report Number
    2124215-2025-19223
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 4, 2025
    Report Date
    August 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729795285
    PMA / PMN Number
    K141521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) K141521, K141597.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: THE MUSTANG WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT APPROXIMATELY 47MM OF THE BALLOON WAS DETACHED AND THE REMAINDER OF THE BALLOON WAS NOTED TO BE BUNCHED AND STILL ON THE SHAFT OF THE DEVICE. THE PART OF THE BALLOON THAT WAS DETACHED WAS NOTED TO HAVE A LONGITUDINAL TEAR AND A COMPLETE CIRCUMFERENTIAL TEAR. A VISUAL AND TACTILE EXAMINATION IDENTIFIED THAT THE SHAFT WAS NOTED TO BE STRETCHED FROM THE PROXIMAL BALLOON BOND DISTALLY TOWARDS THE DISTAL TIP CAUSING THE MARKERBANDS TO BE LOOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST, DIFFICULT TO REMOVE FROM THE GUIDE, AND SURGERY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED ENDOVASCULAR PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS POSITIONED AND INFLATED, BUT THE BALLOON BURST. UPON REMOVAL, IT BECAME STUCK WITH THE GUIDE. THE BALLOON WAS NOT SUCCESSFULLY REMOVED, AND THERE WERE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SHIFTED FROM ENDOVASCULAR TO AN OPEN SURGICAL PROCEDURE TO TREAT THE ARTERIOVENOUS FISTULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST, DIFFICULT TO REMOVE FROM THE GUIDE, AND OPEN SURGERY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED ENDOVASCULAR PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS POSITIONED AND INFLATED, BUT THE BALLOON BURST. UPON REMOVAL, IT BECAME STUCK WITH THE GUIDE. THE BALLOON WAS NOT SUCCESSFULLY REMOVED, AND THERE WERE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SHIFTED FROM ENDOVASCULAR TO AN OPEN SURGICAL PROCEDURE TO TREAT THE ARTERIOVENOUS FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687286 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS LIT BOSTON SCIENTIFIC CORPORATION H74939171120810 0033717693 08714729795285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention